MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-25 for ARCTICSUN 5000 50000000E manufactured by Medivance, Inc. ? 1725056.
[184882257]
The reported event was confirmed as a defective mixing pump. The serial number for the device associated with this particular event (serial number (b)(4): date of manufacture: 01/2016) that was in use at the time this event occurred underwent a manufacturing review and the device history records found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "warnings: do not use the arctic sun? Temperature management system in the presence of flammable agents because an explosion and/or fire may result. Do not use high frequency surgical instruments or endocardial catheters while the arctic sun? Temperature management system is in use. There is a risk of electrical shock and hazardous moving parts. There are no user serviceable parts inside. Do not remove covers. Refer servicing to qualified personnel. Power cord has a hospital grade plug. Grounding reliability can only be achieved when connected to an equivalent receptacle marked? Hospital use? Or? Hospital grade?. When using the arctic sun? Temperature management system, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the arctic sun? Temperature management system may actually alter or interfere with patient temperature control. Do not place arcticgel? Pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient. " the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[184882258]
It was reported that there was a calibration issue on the arctic sun device. The biomed stated she was getting a calibration error 80, and she attempted to calibrate 4 times. The expected was 6 and the actual was 28. 37. Per technical support, it was stated that the biomed called to state that the device was failing calibration for an error 80. Per follow up via phone on 16jan2020, biomed stated they ordered a new part and would fix the device at their facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02091 |
| MDR Report Key | 9878762 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | MEDIVANCE, INC. |
| Manufacturer Street | 321 S TAYLOR AVE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCTICSUN 5000 |
| Generic Name | ARCTIC SUN DEVICE |
| Product Code | DWJ |
| Date Received | 2020-03-25 |
| Model Number | 50000000E |
| Catalog Number | 50000000E |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVANCE, INC. ? 1725056 |
| Manufacturer Address | 321 S TAYLOR AVE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |